Trial Information

Summary: Open-Label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

Open-Label, Single-Arm, Multi-Center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the pharmacokinetics, safety and tolerability of this formulation in children aged 4 to 16 years.

Inclusion Criteria:

• Male or female between 4 and 16 years of age, inclusive.
• The subject suffers from epilepsy (except status epilepticus)
• The subject is requiring levetiracetam IV treatment for a short period of time

Exclusion Criteria:

• The subject has difficult venous accessibility
• The subject is taking more than 2 concomitant AEDs in addition to levetiracetam
• History of status epilepticus during the 3 months prior to V1.
• The subject is taking felbamate at V1 or has been taking it in the past.
• The subject is currently on vigabatrine

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Trial listings updated: June 1, 2008 at 6:43:28 AM